ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
3 March 2005
Application Code
HSR04041
Application Type
To import or manufacture any hazardous substance
under Section 28 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Applicant
Nalco New Zealand Limited
Date Application Received
28 September 2004
Consideration Date
8 February 2005
Considered by
The Hazardous Substances Standing Committee of the
Authority
Purpose of the Application
To manufacture EC6395A for use as a biocide to control
sulphur-reducing bacteria in water separated from
oil/gas production processes
1
Summary of Decision
1.1
The application to import or manufacture EC6395A is approved with controls in
accordance with the relevant provisions of the Hazardous Substances and New
Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO
(Methodology) Order 1998.
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substance Register:
EC6395A
1.3
ERMA New Zealand has adopted the European Union use classification system as the
basis for recording the nature and uses of substances approved. The following use
categories are recorded for this substance:
Main Category:
3
Non-dispersive use
Industrial category:
9
Mineral oil and fuel industry
Function/Use category:
39
Pesticides, non-agricultural.
Subcategory: specialist biocide not
plant protection product.
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 28 of the HSNO Act. The decision was
determined in accordance with section 29, taking into account additional matters to be
considered in that section and matters relevant to the purpose of the Act, as specified
under Part II of the HSNO Act. Unless otherwise stated, references to section numbers
in this decision refer to sections of the HSNO Act.
2.2
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology). Unless
otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3
Application Process
3.1
The application was formally received on 28 September 2004.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 8 October 2004.
3.3
Submissions closed on 22 November 2004.
3.4
No submissions were received.
3.5
Various government departments (including the Ministry of Health and the Department
of Labour (Occupational Safety and Health)), Crown Entities and interested parties,
which in the opinion of the Authority would be likely to have an interest in the
application, were notified of the receipt of the application (sections 53(4) and 58(1)(c),
and clauses 2(2)(e) and 5) and provided with an opportunity to comment or make a
public submission on the application.
3.6
A response was received from the Ministry of Health stating that, “with appropriate
HSNO controls, the Ministry has no issues to raise at this time relating to the acceptance
of this application based on the non-confidential information provided from a public
health perspective (non-occupational).”
3.7
No external experts were used in the consideration of this application (clause 17).
3.8
A public hearing was not required to be held.
3.9
The consideration of the application was originally set down for 17 January 2005 but
was deferred until 8 February 2005 to allow the applicant further time to comment on
the Evaluation and Review (E&R) Report. The applicant’s comments were received on
31 January 2005 and forwarded to the Committee along with a memorandum from the
Agency’s Project Team.
3.10
The following members of the Hazardous Substances Standing Committee considered
the application (section 19(2)(b)): Mr Tony Haggerty (Chairperson), Professor George
Clark and Ms Helen Atkins.
ERMA New Zealand Decision: Application HSR04041
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3.11
The information available to the Committee comprised:
 The application, including confidential appendices;
 The E&R Report;
 Comments from the applicant, on the E&R report;
 Response to the applicant’s comments from the Agency.
4
Consideration
Purpose of the Application
4.1
To manufacture EC6395A for use as a biocide to control sulphur-reducing bacteria in
water separated from oil/gas production processes.
Sequence of the Consideration
4.2
In accordance with clause 24, the approach adopted by the Committee was to:
 Establish the hazard classification for the substance and derive the default controls.
 Identify potentially non-negligible risks, costs, and benefits.
 Assess potentially non-negligible risks, costs, and benefits in the context of the
default controls and possible variations to those controls. Risks were assessed in
accordance with clause 12, and costs and benefits in accordance with clause 13.
 Consider and determine variations to the default controls arising from the
circumstances provided for in sections 77(3), (4) and (5) and then consolidate
controls.
 Evaluate overall risks, costs, and benefits to reach a decision. The combined impact
of risks, costs and benefits was evaluated in accordance with clause 34, and the costeffectiveness of the application of controls was considered in accordance with
clause 35.
Hazard Classification
4.3
The applicant did not agree with the Project Team’s classification of EC6395A. The
Committee reviewed the classification of the substance and concluded that the Project
Team has rightly used the most reliable source of data.
4.4
Accordingly, the Committee has classified the substance in accordance with the project
Team’s determination as follows:
EC6395A
6.1B acute toxic (inhalation)
6.1D acutely toxic (oral)
6.1E acutely toxic (dermal)
6.5A respiratory sensitiser
6.5B contact sensitiser
6.9B harmful to human target organs
8.2B corrosive to dermal tissue
8.3A corrosive to ocular tissue
9.1A very ecotoxic in the aquatic environment
9.2A very ecotoxic in the soil environment
9.3B ecotoxic to terrestrial vertebrate
ERMA New Zealand Decision: Application HSR04041
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Default Controls
4.5
The Committee considered that the E&R Report correctly assigned default controls as
set out in the HSNO Regulations. The default controls were used as the reference for
subsequent consideration of the application; they are identified in the E&R Report
(Table 1, section 8) and are not reproduced here.
Identification of the Significant Risks, Costs and Benefits of the Substance
4.6
The Committee identified potentially non-negligible risks, costs and benefits with
reference to clauses 9 and 11, which incorporate relevant material from sections 2, 5, 6,
and 8.
Risks
4.7
The Committee reviewed the identification of risks made by the applicant and additional
risks identified in the E&R Report.
4.8
The environmental risks arise from possible spillage of the substance at any stage of the
life cycle, resulting in the substance having an adverse effect on aquatic organisms, soil
dwelling organisms or terrestrial vertebrates.
4.9
The human health risks relate to acute oral, dermal and inhalation toxicity, skin and
respiratory sensitisation, skin and eye corrosivity, and target organ toxicity. For an
effect to occur to human health the substance would need to be ingested, inhaled, or
splashed onto skin or into eyes. Acute effects could occur throughout the life cycle.
Chronic effects require repeated exposure and are therefore only likely to occur to
workers during use.
Costs
4.10
A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular
adverse effect expressed in monetary or non-monetary terms”. The Methodology and
the Act both call for consideration of monetary and non-monetary costs (clause 13 and
section 9).
4.11
The Committee is satisfied that there are no significant new or cumulative costs that will
result from the release of this substance.
Benefits
4.12
A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular
positive effect expressed in monetary or non-monetary terms”. Benefits that may arise
from any of the matters set out in clauses 9 and 11 were considered in terms of clause
13.
4.13
The Committee agreed that the following benefits put forward by the applicant, if
realised, are likely to be significant. Use of EC6395A will result in:
 enhanced protection of plant machinery from corrosion;
 improved air quality at the plant site, with associated benefits to the health and
wellbeing of plant workers;
ERMA New Zealand Decision: Application HSR04041
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

reduced incidence of fires caused by combustion of pyrophoric iron;
reduced maintenance times and costs at the facility.
Assessment of the Potentially Non-negligible Risks of the Substance
4.14
The risks assessed were those identified as potentially non-negligible. Risks were
considered in terms of the requirements of clause 12, including the assessment of
consequences and probabilities, the impact of uncertainty and the impact of risk
management.
4.15
The evidence available was largely scientific in nature and was considered in terms of
clause 25(1). This evidence comprised that provided by the applicant and additional
evidence set out in the E&R Report.
4.16
In assessing risk, the Committee gave particular consideration to risks arising from the
significant hazards of the substance i.e. ecotoxicity, and human health effects, and
examined the extent to which exposure to hazard would be mitigated by controls
(clauses 11 and 12).
4.17
The Committee is satisfied that risks to the environment, to Māori, to society, to the
economy and to international obligations are insignificant to low with controls in place,
and insignificant to medium to human health with controls in place.
Assessment of the Potentially Non-negligible Costs and Benefits
4.18
The Methodology and the Act both call for consideration of monetary and nonmonetary costs (clause 13 and section 9). The potentially non-negligible costs are
discussed in paragraphs 4.10 and 4.11. The Committee is satisfied that there are no
significant costs that will result from the release of the substance.
4.19
The potentially non-negligible benefits are discussed in paragraphs 4.12 and 4.13. The
Committee is unable to place an expected value on the benefits (clause 13(b)) but is
satisfied that the ability of the substance to enter the market could give rise to
significant associated benefits.
Establishment of the Approach to Risk in the Light of Risk Characteristics
4.20
Clause 33 requires the Authority, when considering applications, to have regard for the
extent to which a specified set of risk characteristics exist. The intention of this
provision is to provide a route for determining how cautious or risk averse the Authority
should be in weighing up risks and costs against benefits.
4.21
In accordance with clause 33, the Committee has established a cautious position in
weighing up risks and costs against benefits due to the risks posed by the substance to
the environment through spillage and to humans through exposure.
ERMA New Zealand Decision: Application HSR04041
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Overall Evaluation of Risks, Costs and Benefits
4.22
Having regard to clauses 22 and 34 and in accordance with the tests in clause 27 and
section 29, risks, costs and benefits were evaluated taking account of all proposed
controls including default controls plus proposed variations to the controls.
4.23
As indicated in paragraph 4.17 above, the Committee is satisfied that the risks
associated with the substance are insignificant to medium with controls in place.
4.24
As indicated in paragraph 4.19 above, the Committee considers the benefits to plant
machinery; and the health, wellbeing and safety of plant workers are significant.
4.25
In accordance with clause 34, the Committee notes that the most significant risks
associated with the substance primarily involve unprotected bystanders should they be
exposed to the substance following a transportation incident. As such an event is
improbable and it will most likely affect a small number of people at a restricted
location, the Committee concluded, in accordance with clause 27, that the benefits
outweigh the risks and costs.
Variation of Controls under Section 77
4.26
Under section 77(3), (4) and (5), the default controls determined by the hazardous
properties of the substance may be varied.
4.27
The applicant was given an opportunity to comment on the proposed controls as set out
in the E&R Report (clause 35(b)). The applicant did not agree with the Project Team’s
classification of EC6395A which results in the application of an approved handler
control. As discussed in paragraphs 4.3 and 4.4 above, the Committee agrees with the
Project Team’s hazard determination. Furthermore, the Committee is of the view that,
because this substance could be used manually in some instances, it is appropriate to
apply the approved handler control.
4.28
The Committee decided that the following variations should apply to EC6395A:
4.29
Control T2 relates to the requirement to set Workplace Exposure Standards (WES). The
WES set for Component A (WES STEL 0.05ppm) by the Occupational Safety and
Health Service, Department of Labour is set for EC6395A.
4.30
Controls T3 and E5, relating to maintenance of records of use, are deleted (section
77(4)), as the substance is not likely to enter water and leave the site. Any substance
that remains in discharge water will be non-hazardous or unavailable to the
environment.
4.31
Controls T4 and E6, are combined (section 77(5)) as they both relate to requirements for
equipment used to handle hazardous substances.
4.32
Control E1 requires that an Environmental Exposure Limited (EEL) is established. As
the risks to the environment are considered to be insignificant to very low, the EELs
have not been set and the default EEL values for water, soil or sediment have been
deleted (section 77(4)(b)).
ERMA New Zealand Decision: Application HSR04041
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4.33
Control E2 relates to the requirement to set an application rate for any substance which
an EEL has been set for. As no EELs have been set for this substance, this control is
deleted (section 77(4)(b)).
4.34
Control E4 describes controls for the protection of terrestrial vertebrates and applies
only to substances in granular form, coated onto seed or laid as bait. Recognising the
properties of the substance and its life-cycle, the Committee considers that this control
not applicable to the intended use of EC6395A and can be deleted (section 77(4)(a)).
4.35
Controls D4 and D5 are combined (section 77(5)) as they both relate to disposal
requirements.
4.36
Controls P13, P14 and P15 are combined (section 77(5)) as they all relate to packaging
requirements.
4.37
The approved handler Controls (AH1, T6 and E7) and the tracking controls (TR1) are
triggered by the toxicity and ecotoxicity classifications of the substance. The
Committee considers that these controls should apply so as to manage the toxic effects
of the substance.
Additional Controls under s77A
4.38
Under section 77A of the Act, the Authority may impose as controls any obligations and
restrictions that the Authority thinks fit. Before imposing a control under this section,
the Authority must be satisfied that, against any other specified controls that apply to
the substance:
(a) the proposed control is more effective in terms of its effect on the management, use
and risks of the substance; or
(b) the proposed control is more cost-effective in terms of its effect on the management,
use and risks of the substance; or
(c) the proposed control is more likely to achieve its purpose.
4.39
Under section 77(3)(a) of the Act the following additional controls are applied to
EC6395A:
4.40
EC6395A shall only be used in industrial processing facilities.
4.41
This additional control is considered necessary as the risk assessment (paragraphs 4.64.25 above) is based on the importation of EC6395A as a biocide to control sulphurreducing bacteria in water separated from oil/gas production processes. The risk
assessment has not taken into account the discharge of large quantities of this substance
into the environment or the risks associated with the substance being available to the
public.
4.42
The controls relating to stationary container systems and secondary containment,
as set out in Schedules 8 and 9 of the Hazardous Substances (Dangerous Goods and
Scheduled Toxic Substances) Transfer Notice (New Zealand Gazette Issue No 35,
26 March 2004, as amended by Issue No. 128, 1 October 2004, shall apply to this
substance, notwithstanding clause 1 of that schedule.
ERMA New Zealand Decision: Application HSR04041
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4.43
The Committee considers that, as a means of managing the risks from EC6395A,
additional controls relating to stationary container systems and secondary containment
are necessary. In accordance with section 77A(4)(a) of the Act, the Committee is
satisfied that imposing these additional controls is more effective than any other
specified controls in terms of their effect on the management, use and risks of
EC6395A.
Recommendations
4.44
The Committee recommends that, should inappropriate or accidental use, transport or
disposal of EC6395A result in the contamination of waterways, the appropriate
authorities, including the relevant iwi authorities in the region, should be notified. This
action should include advising them of the contamination and the measures taken in
response.
Environmental User Charges
4.45
The Committee considers that use of controls on EC6395A is an effective means of
managing risks associated with this substance. At this time no consideration has been
given to whether or not environmental charges should be applied to this substance as an
alternative or additional means of achieving effective risk management.
5
Decision
5.1
Pursuant to section 29 of the Act, the Committee has considered this application to
import a hazardous substance made under section 28 of the Act.
5.2
The Committee is satisfied that the default controls, as varied in paragraphs 4.26 to
4.43, will be adequate to manage the adverse effects of the hazardous substance.
5.3
Having considered all the possible effects of the hazardous substance in accordance
with section 29 of the Act, pursuant to clause 27 of the Methodology, based on
consideration and analysis of the information provided, and taking into account the
application of controls, the view of the Committee is that the substance poses
insignificant to low risks to the environment to Māori, to society and to the economy
and insignificant to medium risks to human health with controls in place and it is
concluded that the benefits associated with the substance outweigh the risks and costs.
5.4
In accordance with clause 36(2)(b) of the Methodology the Committee records that, in
reaching this conclusion, it has applied the balancing tests in section 29 of the Act and
clause 27 of the Methodology.
5.5
It has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 14 – costs and benefits accruing to New Zealand
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant considerations;
ERMA New Zealand Decision: Application HSR04041
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





5.6
clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
clause 25 – the evaluation of risks;
clause 27 – risks and costs are outweighed by benefits;
clause 33 – risk characteristics;
clause 34 – the aggregation and comparison of risks, costs and benefits; and
clause 35 – the costs and benefits of varying the default controls.
The application for importation and manufacture of the hazardous substance EC6395A
is thus approved, with controls as detailed in Appendix 1.
Tony Haggerty
Date 3 March 2005
Chair Hazardous Substances Committee
ERMA New Zealand Approval Code:
EC6395A: HSR000966
ERMA New Zealand Decision: Application HSR04041
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Appendix 1: List of Controls that apply to EC6395A
Control
Code1
Regulation2
Explanation3
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic and Ecotoxic
Property Controls
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in
the workplace from the adverse effects of toxic substances. A WES is an
airborne concentration of a substance (expressed as mg substance/m3 of
air or ppm in air), which must not be exceeded in a workplace and applies
to every place of work.
T4, E6
7
T5
8
T6
9
T7
10
The following WES applies to this substance:
Component A WES STEL 0.05ppm
Requirements for equipment used to handle EC6395A
Any equipment used to handle EC6395A must retain and/or dispense the
substance in the manner intended, i.e. without leakage, and must be
accompanied by sufficient information so that this can be achieved.
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when EC6395A is being
handled. The clothing/equipment must be designed, constructed and
operated to ensure that the person does not come into contact with the
substance and is not directly exposed to a concentration of the substance
that is greater than the WES for that substance (refer to control T2).
The person in charge must ensure that people using the protective
clothing/equipment have access to sufficient information specifying how
the clothing/equipment may be used, and the requirements for maintaining
the clothing/equipment.
Approved handler requirements
Where EC6395A is held in any quantity, it must generally be under the
personal control of an approved handler, or locked up. However, it may
be handled by a person who is not an approved handler if:
 an approved handler is present at the facility where the substance is
being handled, and
 the approved handler has provided guidance to the person in respect
of handling, and
 the approved handler is available at all times to provide assistance if
necessary.
Restrictions on the carriage of EC6395A on passenger service vehicles
The maximum quantity per package of EC6395A permitted to be carried
on passenger service vehicles is 0.1 litres.
1
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the
hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand website
www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
2
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions. The accompanying explanation is intended for guidance only.
3
These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
Regulation2
Explanation3
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of hazardous substances in terms of:
 information that must be “immediately available” with the substance
(priority and secondary identifiers). This information is generally
provided by way of the product label.
 documentation that must be available in the workplace, generally
provided by way of MSDS.
 Signage at a place where there is a large quantity of the substance.
I1
6, 7, 32-35, 36 General identification requirements
(1)-(7)
These controls relate to the duties of suppliers and persons in charge of
hazardous substances with respect to identification (essentially labelling)
(Regulations 6 and 7), accessibility of the required information
(Regulations 32 and 33) and presentation of the required information with
respect to comprehensibility, clarity and durability (Regulations 34, 35,
36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of any hazardous substance must ensure it is labelled with all
relevant priority identifier information (as required by Regulations 8-17)
and secondary identifier information (as required by Regulations 18-30)
before supplying it to any other person. This includes ensuring that the
priority identifier information is available to any person handling the
substance within two seconds (Regulation 32), and the secondary
identifier information available within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass
that it does not in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of any hazardous substance must ensure it is labelled
with all relevant priority identifier information (as required by
Regulations 8 to 17) and secondary identifier information (as required by
Regulations 18 to 30) before supplying it to any other person. This
includes ensuring that the priority identifier information is available to any
person handling the substance within two seconds (Regulation 32), and
the secondary identifier information available within 10 seconds
(Regulation 33).
Persons in charge must also ensure that no information is supplied with
the substance (or its packaging) that suggests it belongs to a class or
subclass that it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17)
must be available within 2 seconds, eg. on the label
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, eg. on the label.
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability
of information
All required priority and secondary identifiers must be presented in a way
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Control
Code1
Regulation2
I2
8
I3
I8
I9
9
14
18
Explanation3
that meets the performance standards in these Regulations. In summary:
 any information provided (either written and oral) must be readily
understandable and in English
 any information provided in written or pictorial form must be able to
be easily read or perceived by a person with average eyesight under
normal lighting conditions
 any information provided in an audible form must be able to be easily
heard by a person with average hearing
 any information provided must be in a durable format i.e. the
information requirements with respect to clarity must be able to be
met throughout the lifetime of the (packaged) substance under the
normal conditions of storage, handling and use.
Priority identifiers for corrosive substances
This requirement specifies that EC6395A must be prominently identified
as being corrosive. In addition, information must be provided on the need
to prevent access to the substance by children, unless the substance is
being used in a place of work, or part of a place of work, where children
will not lawfully be present.
This information must be available to any person handling the substance
within two seconds (Regulation 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
Priority identifiers for ecotoxic substances
This requirement specifies that EC6395A must be prominently identified
as being ecotoxic.
This information must be available to any person handling the substance
within two seconds (Regulation 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
Priority identifiers for certain toxic substances
This requirement specifies that EC6395A must be prominently identified
as being toxic. In addition, information must be provided on the general
degree and type of hazard of the substance, and the need to restrict access
to the substance by children.
This information must be available to any person handling the substance
within two seconds (Regulation 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
Secondary identifiers for all hazardous substances
This control relates to detail required for EC6395A on the product label.
This information must be accessible within 10 seconds (Regulation 33)
and could be provided on secondary panels on the product label. The
following information is required:
 an indication (which may include its common name, chemical name,
or registered trade name) that unequivocally identifies it, and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone, and
 in the case of a substance which, when in a closed container, is likely
to become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it
is likely to occur.
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Control
Code1
I10
Regulation2
19
I11
20
I16
25
I17
26
Explanation3
Secondary identifiers for corrosive substances
This control relates to the additional label detail required for EC6395A.
This information must be accessible within 10 seconds (Regulation 33)
and could be provided on secondary panels on the product label. The
following information must be provided:
 an indication of its general degree and general type of corrosive
hazard (eg. corrosive to the skin and eyes)
 an indication of the circumstances in which it may harm skin or eye
tissue, and the type and extent of harm it is likely to cause
 the name and concentration of any ingredient that would
independently of any other ingredient, cause the substance to be
classified as either a class 8.2 or 8.3. For this substance, this is
Components A and B.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for EC6395A.
This information must be accessible within 10 seconds (Regulation 33)
and could be provided on secondary panels on the product label. The
following information must be provided:
 an indication of the circumstances in which it may harm living
organisms
 an indication of the kind and extent of the harm it is likely to cause to
living organisms
 an indication of the steps to be taken to prevent harm to living
organisms
 an indication of its general type and degree of hazard (eg. very toxic
to aquatic life)
 an indication of its general type of hazard (eg. very toxic to soil
organisms)
Secondary identifiers for toxic substances
This control relates to the additional label detail required for EC6395A.
This information must be accessible within 10 seconds (Regulation 33)
and could be provided on secondary panels on the product label. The
following information must be provided:
 an indication of its general type and degree of toxic hazard (eg. highly
toxic by inhalation)
 an indication of the circumstances in which it may harm human
beings
 an indication of the kinds of harm it may cause to human beings, and
the likely extent of each kind of harm
 an indication of the steps to be taken to prevent harm to human beings
 the name and concentration of any ingredient that would
independently of any other ingredient, cause the substance to be
classified as either a class 6.1B, 6.5, or 6.9, i.e. Components A and B
Use of Generic Names
This control provides the option of using a generic name to identify
specific ingredients (or groups of ingredients) where such ingredients are
required to be listed on the product label as specified by Regulations 19(f)
and 25(e) and (f).
(Regulations 19(f) and 25(e) and (f) specify a requirement to list on the
product label, the name and concentration of any ingredient that would
independently of any other ingredient, cause the substance to be classified
as either 6.1B, 6.1D, 6.5, 6.9, 8.2 or 8.3), i.e. Components A and B.
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Control
Code1
I18
I19
Regulation2
27
29-31
Explanation3
Use of Concentration Ranges
This control provides the option of providing concentration ranges for
those ingredients whose concentrations are required to be stated on the
product label as specified by Regulations 19(f) and 25(e) and (f).
(Regulations 19(f) and 25(e) and (f) specify a requirement to list on the
product label, the name and concentration of any ingredient that would
independently of any other ingredient, cause the substance to be classified
as either 6.1B, 6.1D, 6.5, 6.9, 8.2 or 8.3), i.e. Components A and B.
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when
substances are contained in fixed bulk containers or bulk transport
containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of the
substance.
Regulation 29(2) specifies that for bulk transport containers, it is
sufficient compliance if the substance is labelled or marked in compliance
with the requirements of the Land Transport Rule 45001, Civil Aviation
Act 1990 or Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when hazardous substances are in
multiple packaging and the outer packaging obscures some or all of the
required substance information. In such cases, the outer packaging must:
 be clearly labelled with all relevant priority identifier information i.e.
the hazardous properties of the substance must be identified, or
 be labelled or marked in compliance with either the Land Transport
Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994
as relevant, or
 it must bear the EU pictogram “Dangerous to the Environment”
(‘dead fish and tree’ on orange background), or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
I20
36(8)
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for
hazardous substances that are imported into New Zealand in a closed
package or in a freight container and will be transported to their
destination without being removed from that package or container. In
these situations, it is sufficient compliance with HSNO if the package or
container is labelled or marked in compliance with the requirements of the
Land Transport Rule 45001.
Durability of information for class 6.1 substances
Any packaging in direct contact with EC6395A must be permanently
identified as having contained a toxic substance, unless the substance as
packaged is restricted to a place of work.
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
I21
Regulation2
37-39, 47-50
Explanation3
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Material Safety Data Sheets) (Regulations 37, 38 and 50); the general
content requirements of the documentation (Regulation 39 and 47); the
accessibility and presentation of the required documentation with respect
to comprehensibility and clarity (Regulation 48).
These controls are triggered when EC6395A is held in the workplace in
any quantity, as specified in Schedule 2 of the Identification Regulations.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant
information required by Regulations 39 to 48 when selling or supplying to
another person a quantity of a hazardous substance equal to or greater than
the levels specified in Schedule 2 for that classification, if the substance is
to be used in a place of work and the supplier has not previously provided
the documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of
work
The person in charge of any place of work where hazardous substances
are present in quantities equal to or greater than those specified in
Regulation 38 (and with reference to Schedule 2 of the Identification
Regulations), must ensure that every person handling the substance has
access to the documentation required for each hazardous substance
concerned. The person in charge must also ensure that the documentation
does not contain any information that suggests that the substance belongs
to a class or subclass it does not in fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with a hazardous substance must include the
following information:
 the unequivocal identity of the substance (eg. the CAS number,
chemical name, common name, UN number, registered trade name(s))
 a description of the physical state, colour and odour of the substance
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a
description of the temperatures at which the changes in physical state
may occur and the nature of those changes.
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and
the date by which it is likely to occur
 contact details for the New Zealand supplier/manufacturer/importer
 all emergency management and disposal information required for the
substance
 the date on which the documentation was prepared
 the name, concentration and CAS number of any ingredients that
would independently of any other ingredient, cause the substance to
be classified as either a class 6.1B, 6.1D, 6.5, 6.9, 8.2 or 8.3. ), i.e.
Components A and B.
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
Regulation2
Explanation3
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (eg. as provided on an MSDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance
with those Regulations if reference is made to that information
requirement along with a comment indicating that such information is not
applicable to that substance.
Regulation 48 – Location and presentation requirements for
documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must
be readily understandable by any fully-trained worker required to have
access to it and must be easily read, under normal lighting conditions, at a
distance of not less than 0.3m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
I22
40
I23
41
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the
required documentation to any person in charge of a place of work (where
a hazardous substance is present) if asked to do so by that person.
Specific documentation requirements for corrosive substance
The documentation provided with EC6395A must include the following
information:
 its general degree and type of corrosive hazard (eg. corrosive to the
skin and eyes)
 a full description of the circumstances in which it may cause
unintentional damage to tissue
 a full description of the potential consequences of any damage it may
cause to tissue
 a full description of the steps to be taken to prevent unintentional
damage to tissue
 its pH or pH range.
Specific documentation requirements for ecotoxic substances
The documentation provided with EC6395A must include the following
information:
 its general degree and type of ecotoxic hazard (eg. highly ecotoxic to
aquatic and soil environments)
 a full description of the circumstances in which it may harm living
organisms and the extent of that harm
 a full description of the steps to be taken to prevent harm to living
organisms
 a summary of the available acute and chronic (ecotox) data used to
define the (ecotox) subclass or subclasses in which it is classified
 its bio-concentration factor or octanol-water partition coefficient
 its expected soil or water degradation rate
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
I28
Regulation2
46
Explanation3
Specific documentation requirements for toxic substances
The documentation provided with EC6395A must include the following
information:
 its general degree and type of toxic hazard
 a full description of the circumstances in which it may harm human
beings
 the kinds of harm it may cause to human beings
 a full description of the steps to be taken to prevent harm to human
beings
 if it will be a liquid during its use, the percentage of volatile substance
in the liquid formulation, and the temperature at which the
percentages were measured
 a summary of the available acute and chronic (toxic) data used to
define the (toxic) subclass or subclasses in which it is classified
 the symptoms or signs of injury or ill health associated with each
likely route of exposure
 the dose, concentration, or conditions of exposure likely to cause
injury or ill health
 the WESs set by the Authority.
Component A WES STEL 0.05 ppm
I29
51-52
Duties of persons in charge of places with respect to signage
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where EC6395A is held in
quantities exceeding 100 litres.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present
 at each entrance to rooms or compartments where hazardous
substances are present
 immediately adjacent to the area where hazardous substances are
located in an outdoor area.
The information provided in the signage needs to be understandable over
a distance of 10 metres and be sufficient to:
 advise that the location contains hazardous substances
 describe the general type of hazard of each substance (e.g. corrosive)
 where the signage is immediately adjacent to the hazardous substance
storage areas, describe the precautions needed to safely manage the
substance (eg. wear protective clothing for corrosive substances).
I30
53
Advertising EC6395A
Any advertisement for EC6395A must include information that identifies
the substance is toxic, specifies its general degree and type of hazard and
indicates the need to restrict access by children.
Any advertisement must also include information that identifies the
substance is corrosive and indicates the need to restrict access by children
(unless the substance is to be used in a place of work where children may
not lawfully be present).
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
Regulation2
Explanation3
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance
with any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for all hazardous substances must ensure that, when the
package is closed, there is no visible release of the substance, and that it
maintains its ability to retain its contents in temperatures from –10oC to
+50oC. The packaging must also maintain its ability to retain its remaining
contents if part of the contents is removed from the package and the
packaging is then re-closed. The packaging in direct contact with the
substance must not be significantly affected or weakened by contact with
the substance such that the foregoing requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing hazardous substances must not be marked in
accordance with the UN Model Regulations unless:
 the markings comply with the relevant provisions of that document,
and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively, and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
 When packing any hazardous substance, account must be taken of its
physical state and properties, and packaging must be selected that
complies with the requirements of Regulation 5, and Regulations 9 to
21.
Regulation 8 – Compatibility
Hazardous substances must not be packed in packaging that has been
previously packed with substances with which it is incompatible unless all
traces of the previous substance have been removed.
Regulation 9A and 9.B – Large Packaging
Large packaging may be used to contain hazardous substances in New
Zealand if it has been constructed, marked and tested as a large package as
provided in Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003.
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004, or
 a stationary container system, a stationary tank or a tank (as defined in
the Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
ERMA New Zealand Decision: Application HSR04041
Page 18 of 23
Control
Code1
P3
Regulation2
9
Explanation3
Packaging requirements for substances packed in limited quantities
When EC6395A is packaged in quantities up to 0.1L, it may be packaged
to a lesser performance standard than normally required (as specified in
Schedule 4 of the Packaging Regulations).
P13, P14, 19, 20, 21
Packaging requirements for EC6395A
P15
The packaging requirements for EC6395A are as follows:
 In quantities of more than 0.1L, it must be packaged according to
Schedule 2 (UN PGII), but may be packaged according to either
Schedule 2 or Schedule 4 when in quantities equal to or less than
0.1L.
 If offered for sale in a package of less than 2.5L, EC6395A must be in
child resistant packaging. However, if the substance is for use in a
place of work to which children to not have access, this requirement is
not mandatory.
PG2
Schedule 2
This schedule describes the (minimum) packaging requirements that must
be complied with for this substance. The tests in Schedule 2 correlate to
the packaging requirements of UN Packing Group II (UN PGII).
PS4
Schedule 4
This schedule describes the (minimum) packaging requirements that must
be complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
D4, D5
8, 9
Disposal requirements for EC6395A
EC6395A must be disposed of by:
 treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with
any other substance prior to discharge to the environment; or
 discharging the substance to the environment provided that after
reasonable mixing, the concentration of the substance in any part of
the environment outside the mixing zone does not exceed any EEL or
TEL set by the Authority for that substance; or
 exporting the substance from New Zealand as a hazardous waste
D6
10
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
EC6395A and are no longer to be used for that purpose. Such packages
must be either decontaminated/treated or rendered incapable of containing
any substance (hazardous or otherwise) and then disposed of in a manner
that is consistent with the disposal requirements for the substance. In
addition, the manner of disposal must take into account the material that
the package is manufactured from.
D7
11, 12
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying
any quantity of EC6395A.
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should
be avoided, i.e. that would not comply with the Disposal Regulations.
Such information must be accessible to a person handling the substance
within 10 seconds and must comply with the requirements for
comprehensibility, clarity and durability as described in Regulations 3436 of the Identification Regulations (code I1).
ERMA New Zealand Decision: Application HSR04041
Page 19 of 23
Control
Code1
D8
Regulation2
13, 14
Explanation3
Disposal documentation requirements
These controls relate to the provision of documentation concerning
disposal (essentially in a MSDS) that must be provided when selling or
supplying any quantity of EC6395A.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person
handling the substance at a place of work within 10 minutes and must
comply with the requirements for comprehensibility and clarity as
described in Regulations 48(2), (3) and (4) of the Identification
Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management
information (essentially on the label) that must be provided with
any quantity of EC6395A.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the
requirement for the availability of the information (10 seconds) and
Regulation 10 gives the requirements relating to the presentation of the
information with respect to comprehensibility, clarity and durability.
These requirements correspond with those relating to secondary identifiers
required by the Identification Regulations (code I1, Regulations 6, 7, 32–
35, 36(1)-(7)).
EM2
8(a)
EM6
8(e)
EM7
8(f)
EM8
12-16, 18-20
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being
transported.
Information requirements for corrosive substances
The following information must be provided with any quantity of
EC6395A:
 A description of the usual symptoms of exposure
 a description of the first aid to be given
 a 24-hour emergency service telephone number.
Information requirements for toxic substances
The following information must be provided with any quantity of
EC6395A:
 a description of the first aid to be given
 a 24-hour emergency service telephone number.
Information requirements for ecotoxic substances
The following information must be provided with EC6395A when present
in quantities equal to or greater than 0.1 litres:
 a description of the parts of the environment likely to be immediately
affected by it:
 a description of its typical effects on those parts of the environment
 a statement of any immediate actions that may be taken to prevent the
substance from entering or affecting those parts of the environment.
Level 2 emergency management information requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Material Safety Data Sheets). This
ERMA New Zealand Decision: Application HSR04041
Page 20 of 23
Control
Code1
Regulation2
Explanation3
documentation must be provided where EC6395A is sold or supplied, or
held in a workplace, in any quantity.
Regulations 12 and 13 describe the duties of suppliers, regulation 14
describes the duties of persons in charge of places of work, regulation 15
provides for the option of complying with documentation requirements of
the transport rules when the substance is being transported, and regulation
16 specifies requirements for general contents of the documentation.
EM11
EM12
EM13
25-34
35-41
42
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements
correspond with those relating to documentation required by the
Identification regulations (code I21).
Level 3 emergency management requirements – emergency response
plans
These Regulations relate to the requirement for an emergency response
plan to be available at any place (excluding aircraft or ships) where
EC6395A is held (or reasonably likely to be held on occasion) in
quantities greater than 100 litres.
The emergency response plan must describe all of the likely emergencies
that may arise from the breach or failure of controls. The type of
information that is required to be included in the plan is specified in
Regulations 29 to 30. Requirements relating to the availability of
equipment, materials and people are provided in Regulation 31,
requirements regarding the availability of the plan are provided in
Regulation 32 and requirements for testing the plan are described in
Regulation 33.
Level 3 emergency management requirements – secondary
containment
These Regulations relate to the requirement for a secondary containment
system to be installed at any fixed location where EC6395A is held in
quantities equal to or greater than 100 litres.
Regulation 37 prescribes requirements for places where hazardous
substances are held above ground in containers each holding up to 60L or
less. Regulation 38 prescribes requirements for places where hazardous
substances are held above ground in containers each holding between 60L
and 450L. Regulation 39 prescribes requirements for places where
hazardous substances are held above ground in containers each holding
more than 450L. Regulation 40 prescribes requirements for places where
hazardous substances are held underground. Regulation 41 prescribes
requirements for secondary containment systems that contain substances
of specific hazard classifications.
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management
information on signage at places where EC6395A is held at quantities
equal to or greater than 100 litres.
The signage must advise of the action to be taken in an emergency and
must meet the requirements for comprehensibility and clarity as defined in
Regulations 34 and 35 of the Identification Regulations.
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
Regulation2
Explanation3
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
EC6395A is required to be under the control of an approved handler (see
control T6).
An approved handler is a person who holds a current test certificate
certifying that they have met the competency requirements specified by
the Personnel Qualification Regulations in relation to handling specific
hazardous substances.
Regulation 4 describes the test certification requirements, regulation 5
describes the qualification (competency and skill) requirements and
regulation 6 describes situations where transitional qualifications for
approved handlers apply.
Hazardous Substances (Tracking) Regulations 2001
TR1
4(1), 5, 6
General tracking requirements
EC6395A is subject to tracking requirements, i.e. the location and
movement of the substance must be recorded at each stage of its lifecycle
until its final disposal.
The person in charge of the place where the tracked substance is kept is
responsible for ensuring that the necessary information is included in the
record. This information to be provided is specified in Schedule 2 of the
Tracking Regulations, and includes information on the identification of
the approved handler, and on the identification, quantity, location and
disposal of the substance. The record must meet the location and
presentation requirements specified in Part 2 of the Identification
Regulations, i.e. it must be accessible within 10 minutes and meet the
performance standards for comprehensibility and clarity [Regulation 5(1)
and (2)].
If a tracked substance is transferred to another place, the person in charge
must ensure that the record is retained for a period of 12 months. If the
substance has undergone treatment that results in it no longer being a
tracked substance, or if it has been intentionally or unintentionally
disposed of, the record must be kept for 3 years. However these
requirements do not apply to places that are vehicles. [Regulation 5(3)
and (4)].
Regulation 6 prescribes requirements relating to the transfer of tracked
substances from one place to another. Specifically, the person in charge
may only transfer the tracked substance to another place if they have
received confirmation that:
 an approved handler is present at the place receiving the substance
 the place receiving the substance meets any location test certification
requirements
 any place where the substance is to be held during transit complies
with the relevant requirements of the Hazardous Substances
(Emergency Management) Regulations and Hazardous Substances
(Classes 1 to 5 Controls) Regulations.
ERMA New Zealand Decision: Application HSR04041
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Control
Code1
Regulation2
Explanation3
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations
Regs 4 to 43
These regulations specify requirements for various types of tanks, tank
where
wagons and transportable containers that carry hazardous substances and
applicable
should be complied with as relevant.
S77A controls
EC6395A shall only be used in industrial processing facilities.
The controls relating to stationary container systems and secondary containment, as set out in Schedules
8 and 9 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer
Notice (New Zealand Gazette Issue No 35, 26 March 2004, as amended by Issue No. 128, 1 October
2004) shall apply to this substance, notwithstanding clause 1(1) of those schedules.
ERMA New Zealand Decision: Application HSR04041
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